Immunoregulatory Effects of Immunoglobulin Induction Therapy in Renal Transplant Recipients

Early Phase 1

Completed

• Conditions: Renal Failure, Chronic; Renal Transplantation

• Registration Number: NCT00176059
• Lead Sponsor: University of Giessen

Brief Summary

The aim of this randomized prospective study in renal transplant recipients is to investigate immunological short and long-term effects of an IVIG induction therapy.

Furthermore clinical endpoints (patient and graft survival, incidence of acute and chronic rejection, infectious diseases and graft function) up to three years posttransplant will be analyzed.

Detailed Description

Intravenous immunoglobulin (IVIG) preparations are known to be effective in the treatment of various autoimmune and inflammatory disorders due to their immunomodulatory and antiinflammatory properties. It has been demonstrated that IVIG is effective in the treatment of acute vascular rejection and steroid resistant cellular rejection. Furthermore, IVIG has been used to inhibit production of lymphocytotoxic antibodies in highly sensitized patients so that successful cadaveric or living renal transplantation could be performed.

The aim of this randomized prospective study in renal transplant recipients is to investigate immunological short and long-term effects of an IVIG induction therapy on Th1, Th2 and B-cell/monocyte responses, expression of adhesion molecules, costimulatory factors and cytokine receptors and on secretion of immunoregulatory autoantibodies (anti-F(ab)-, anti-F(ab')2G-, anti-hinge autoantibodies). These autoantibodies have been shown to significantly affect the risk of chronic rejection and graft loss.

Furthermore, clinical endpoints (patient and gaft survival, incidence of acute and chronic rejection, infectious diseases and graft function) up to 3 years will be analyzed.

Study Timeline

• Study Start: 2001-10
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Study Completion: 2006-05
• Status Verified: 2007-05
• Last Update Submitted: 2007-05-08
• Last Update Posted: 2007-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• renal transplant recipients of the Giessen renal transplant unit
• cadaveric and living renal transplants
• first and retransplants

Exclusion Criteria

• Contraindications against blood-taking (anaemia with hemoglobin < 9,5 g/l, hypotension)
• intravenous immunoglobulin therapy in the last half year before study entry
• Hyperimmunoglobulin therapy for severe CMV infection
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
patient survival	1 year / 3 years / 5 years posttransplant
graft survival	1 year / 3 years / 5 years posttransplant
acute rejection	1 year
chronic allograft nephropathy	3 years / 5 years posttransplant

Secondary Outcome Measures

Name	Time	Method
graft function	1 year / 3 years / 5 years
infectious complications	1 year
immunoglobulin levels	1 year
regulatory autoantibody levels	1 year / 3 years / 5 years
Th1 and Th2 responses	1 year / 3 years
B-cell/monocyte responses	1 year / 3 years
Expression of adhesion molecules, costimulatory molecules and cytokine receptors	1 year / 3 years
proteinuria (quantitative assessment)	1 year / 3 years

Trial Locations

Locations (1)

Department of Internal Medicine, University of Giessen; 🇩🇪 Giessen, Germany